Congress overturns veto of the Law on Research with Human Beings and reestablishes deadline for supply of experimental drugs

In a session held yesterday (June 17), the National Congress decided to override Veto No. 13/2024, which had been partially imposed on Law No. 14,874/2024, which regulates the conduct of research with human beings in Brazil.

Provisions originally vetoed by the Presidency of the Republic come into force

1. Article 24, 3, which determines the mandatory communication to the Public Prosecutor’s Office about the participation of members of indigenous groups in research; and
2. Item VI of article 33, which authorizes the sponsor to interrupt the free supply of the investigational drug within the scope of the post-study supply program to the research participant after a period of five (5) years from its commercial availability in Brazil.

The overturned veto comes approximately one year after the enactment of Law No. 14,874/2024, which still requires regulation in certain aspects, such as the rules governing the post-study provision program and the structuring of the National Research Ethics Body — both considered important for the full implementation of the new legal framework.

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